Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | EBI BONE HEALING SYSTEM |
Generic Name | Stimulator, bone growth, non-invasive |
Applicant | EBI, LLC 1 Gatehall Drive Suite 303 Parsippany, NJ 07054 |
PMA Number | P790002 |
Supplement Number | S023 |
Date Received | 06/17/2005 |
Decision Date | 09/26/2005 |
Product Code |
LOF |
Advisory Committee |
Orthopedic |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THREE NEW COILS: THE FLX 5, THE XL COILETTE AND THE MINI COILETTE AND A MODIFIED VERSION OF THE BONE HEALING SYSTEM MODEL 2001 CONTROLLER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME EBI BONE HEALING SYSTEM AND IS INDICATED FOR THE TREATMENT OF FRACTURE NON-UNIONS, FAILED FUSIONS, AND CONGENITAL PSEUDOARTHROSES IN THE APPENDICULAR SYSTEM. |
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